ENGR9742: Ethical Analysis of Artificial Heart Valve Case Study

This report examines the ethical issues surrounding the manufacturing and use of an artificial heart valve, focusing on a case study involving Pfizer. The study identifies ethically relevant factors, such as lack of proper care during manufacturing, and the failure to adequately test the device before human implantation. The report details the decision timeline, highlighting the financial aspects and the eventual malfunctioning of the valve, leading to patient deaths and economic losses for the company. Ethical conditions like informed consent, conflict of interest, and professional self-regulation are analyzed, along with the links between these conditions and the stakeholders involved. The outcomes of these ethical implications, including the government's decision to halt production, are discussed, emphasizing the need for ethical considerations in biomedical engineering. The report concludes that the case study underscores the importance of ethical practices to prevent failures and protect both patients and manufacturers.

Running head: ARTIFICIAL HEART VALVE, AN ETHICAL CASE STUDY
ARTIFICIAL HEART VALVE, AN ETHICAL CASE STUDY
Name of the Student
Name of the University
Author Note

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Running head: ARTIFICIAL HEART VALVE, AN ETHICAL CASE STUDY
Abstract
This paper focusses in discussing the ethical factors and their outcomes associated with the
manufacture of an artificial heart valve. Pfizer is a company, which manufactured artificial
heart valves in New York. However, malfunctioning occurred due to the existence of ethical
issues during the process of manufacture. Therefore the need for ethical considerations is
discussed in the following sections.

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Running head: ARTIFICIAL HEART VALVE, AN ETHICAL CASE STUDY
Table of Contents
Introduction:...............................................................................................................................3
Identification of the case study:.............................................................................................3
Decision timeline:..................................................................................................................3
Discussion:.................................................................................................................................4
Ethically relevant factors:......................................................................................................4
Ethical conditions:..................................................................................................................5
The link between ethical conditions and the associated parties:............................................6
Outcomes of the ethical implications:....................................................................................7
Conclusion:................................................................................................................................8
References:.................................................................................................................................9

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Running head: ARTIFICIAL HEART VALVE, AN ETHICAL CASE STUDY
Introduction:
Identification of the case study:
The case study taken for this study involves the use of artificial heart valves in New
York (The Associated Press, 1992). The artificial heart valve is the discovery of biomedical
engineering, which is used as a substitute for a nonfunctional native heart valve (Kheradvar
et al. 2015). In this case, a healthcare company known as Pfizer manufactured study, artificial
heart valve. This product was sold in New York from 1979 to 1986 by a subsidiary of Pfizer.
This device was implanted in 55,000 patients throughout the world. A high amount of
investment was made for the production of an artificial heart valve. However, defects in the
associated heart valve posed a substantial impact on the health of patients. An internal
fracture in the machine caused the defect, and their dysfunction caused deaths among many
people. This condition was controlled by doing some modifications in the valve, and the
death rate reduced gradually. However, since the manufacturing process was costly, and the
results included deaths of patients, the government did not allow the future manufacture of
the products. Thus, it can be stated that this case study is based on biomedical engineering
and has ethical issues associated with it. The following sections will discuss the points of
identification of the case study, ethical issues and the outcomes of the ethical implications
related to this case study.
Decision timeline:
Cost of implementing the device was stated to be around two hundred million dollars.
This factor was left for the court to approve on 5 June. Ninety-nine per cent of the
implemented heart valves were found to be successful in their functioning. An amount with
the fourth quarter of $900,000 gave rise to a profit of $195 million per year. The revenue
raised to a higher value due to an increase in mortality due to malfunctioning of the device.

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Running head: ARTIFICIAL HEART VALVE, AN ETHICAL CASE STUDY
Discussion:
Ethically relevant factors:
The primary ethically relevant factor is the lack of proper care while manufacturing
the artificial heart valve. This condition is relevant from the fact that the high mortality rates
were observed for the patients with a defective artificial heart valve. According to Kheradvar
et al. (2015), metal struts play an essential role in the functioning of an artificial heart valve.
According to this case study, the malfunctioning of the artificial heart valve was because the
metal wires and the struts that hold the disk have fractured. Therefore, blood was flowing
throughout the body without being controlled by a heart valve (Bishop, Uong and Lashinski
2016). This condition caused death among the patient population in which the artificial valve
was implanted. Both the patient population and the manufacturing team were profoundly
affected by this loss. The government prevented further manufacturing and selling of this
prosthetic heart valve. Another ethically relevant factor involved in this study is the failure of
the testing process in a model organism before being applied to human beings. Most of the
biomedically engineered products are first tested for their efficiency in a model organism and
then implemented in human beings (Andrés-Delgado and Mercader 2016). The company did
take a step to control the failure of heart valves by replacing the double metal struts by a
single metal strut, but it was too late and not very useful when compared to the number of
patients died due to the valve failure. Testing the artificial heart valve in a model organism
would have brought out this failure at an initial stage where it could have been resolved. The
lawyers associated with the patients filed cases against the company for manufacturing the
heart valves. This fact posed a significant impact on the economy of the associated
manufacturing company of artificial heart valves. Both the company and the patients' were
the affected parties since they suffered a substantial economic loss. No other ethically
relevant factors have arisen in this case study since the manufacturing company was banned

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Running head: ARTIFICIAL HEART VALVE, AN ETHICAL CASE STUDY
from further productions of artificial heart valves. These ethical factors were also observed in
another case study involving the application of biomedical engineering in the human
community (Idkaidek and Jasiuk 2017). The teleological ethical theory supports this case
study since it deals with "Eudaimonism” (Westermarck 2017). This theory leads to the well
being of human beings and is directly associated with medical procedures. Since artificial
heart valves are the primary concern here, this theory has been used to justify this case study.
Ethical conditions:
Informed consent, conflict of interest and professional self-regulation are the three
main ethical issues associated with this case study. Since the patients were assured of the fact
that they would get cured of the artificial implantation, which failed to result in ethical issues
(Ramos and McCauley 2017.). In this case, study, both risks and benefits exist for the above
stated ethical conditions. The primary risk for the above case study is the death of patients
occurring due to the failure of artificial heart valves. According to the case study, two out of
three patients with a malfunction in the artificial heart valves die due to uncontrollable blood
flow throughout the body. Massive economic loss is another risk for the stakeholders
associated with the company since the production of the artificial valves 1.79 billion dollars.
According to the case study, this cost raised revenue of 1.85 billion in the next year.
Therefore, the stakeholders of the company suffered substantial economic loss. Since the
stakeholders of the company include manufacturers and the investors, they were the one who
suffered the loss at its extremes (Tompa et al. 2016). Another risk was that the expenditure of
funds provided by the government in order to manufacture the product. The government
finally stopped the manufacturing of the product since the company had a deficit in paying
the taxes. Therefore this risk could have been resolved if the artificial heart valves were tested
in a model organism before applying in patients. However, benefits also existed for the
ethical conditions stated in the previous sections. Artificial heart valves are time-consuming

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Running head: ARTIFICIAL HEART VALVE, AN ETHICAL CASE STUDY
and are an efficient device for substituting nonfunctional human heart valves (Sievers 2017).
This convexo-concave valve was very effective in controlling the blood flow in patients
unless the cases of failure occurred. The associated company was also observing a profit each
year from the selling of the product. This profit was high enough to allow the company to
preserve a specific amount of fund to the failed cases. However, the deaths occurring due to
internal fractures in the artificial heart valves led the company to modify the product. The
decision was taken to modify the double metal strut valve to a single strut valve, which
reduced the number of deaths to a certain extent. According to Conklin et al. (2017), meal
struts plays an essential role in the functioning of artificial heart valves. However, the
government and the company already suffered a loss due to a failure of the previous device
and manufacturing process was stopped. The government decided to stop the company from
manufacturing artificial heart valves in future. The overall outcome of the process arose due
to lack of proper care for ethical considerations before the manufacturing process.
The link between ethical conditions and the associated parties:
The risk and benefits were related to the stakeholders of the company. This is because
of the fact that Pfizer manufactured the artificial heart valves, which were time-consuming in
their application. The benefits were directly proportional to the associated parties
(manufacturers, investors and workers of Pfizer) since the most significant benefit was the
economic profit they were getting from the selling of artificial heart valves. According to
Vyavahare and Tam (2018), stakeholders play an essential role in providing financial support
to the manufacturing unit. Therefore, they are the ones who receive the highest percentage of
profit after the manufactured product is successfully marketed. However, the benefits are far
less than the risk factors associated with this case study. According to this case, the company
suffered a substantial economic loss followed by the closure of the manufacturing of an
artificial heart valve due to the failure of their product. This is the most significant risk, which

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Running head: ARTIFICIAL HEART VALVE, AN ETHICAL CASE STUDY
is connected to any manufacturing unit. According to Khajavi et al. (2015), recovering the
amount invested for the launching of a new product (heart valve for this study) is the primary
criteria for any manufacturing unit. However, this company failed to achieve the goal since
the non-functioning of their product caused numerous deaths in the associated human
population. As a result, it can be stated that the stakeholders are connected to benefits and
risks in terms of the economy.
Outcomes of the ethical implications:
After analyzing the ethical considerations, it can be stated that the case failed in terms
of ethics. This condition arose due to the fact that the company did not take responsibility for
some ethical considerations before manufacturing the artificial heart valve. The closure of the
manufacture of the company as a result of absolute economic loss suffered due to the
improper functioning of the manufactured heart valves. Deaths were rising due to the internal
fracture found in the artificial heart valves, and thus, newer modifications were required. The
company failed to test the product in model organisms in order to reduce their economic
investments, as it was already a costly process. The outcome of the above condition was a
rapid failure of the product after being launched. The company was also getting enough profit
from the manufactured product; however, it failed due to lack of care during the production
of artificial heart valves. These outcomes can be directly linked to the teleological ethical
theory, as stated before, since it revolved around informed consent and lack of professional
responsibility in the manufacturers. The government and the patients were not aware of the
fact that the convexo-concave heart valve was an untested product. As a result, it can be said
that the outcomes were directly linked to the ethical issues stated in the previous sections.

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Running head: ARTIFICIAL HEART VALVE, AN ETHICAL CASE STUDY
Conclusion:
From the above discussion, it can be stated that the study focused on the
manufacturing of an artificial heart valve and the outcomes of its use in the human
community. This case study consisted of ethical issues, which failed the functioning of the
artificial heart valve. The company, government and the associated patient suffered a
significant loss in terms of their lives and economy. Therefore, the manufacturing of artificial
heart valves was stopped by the government since the outcomes of inappropriate
considerations of ethical issues were not acceptable. Thus the requirement of prior notice
towards ethical consideration is necessary for a manufacturing unit so that the chances of
failures are reduced.

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Running head: ARTIFICIAL HEART VALVE, AN ETHICAL CASE STUDY
References:
Andrés-Delgado, L. and Mercader, N., 2016. Interplay between cardiac function and heart
development. Biochimica et Biophysica Acta (BBA)-Molecular Cell Research, 1863(7),
pp.1707-1716.
Bishop, G.B., Uong, D. and Lashinski, R.T., Direct Flow Medical Inc, 2016. Translumenally
implantable heart valve with formed in place support. U.S. Patent 9,308,360.
Conklin, B.S., Zeng, Q., Howanec Jr, M. and Kim, G.M., Edwards Lifesciences Corp,
2017. Integrated hybrid heart valves. U.S. Patent Application 15/199,748.
Idkaidek, A. and Jasiuk, I., 2017. Cortical bone fracture analysis using XFEM–case
study. International journal for numerical methods in biomedical engineering, 33(4),
p.e2809.
Khajavi, S.H., Partanen, J., Holmström, J. and Tuomi, J., 2015. Risk reduction in new
product launch: A hybrid approach combining direct digital and tool-based
manufacturing. Computers in Industry, 74, pp.29-42.
Kheradvar, A., Groves, E.M., Dasi, L.P., Alavi, S.H., Tranquillo, R., Grande-Allen, K.J.,
Simmons, C.A., Griffith, B., Falahatpisheh, A., Goergen, C.J. and Mofrad, M.R., 2015.
Emerging trends in heart valve engineering: part I. Solutions for future. Annals of biomedical
engineering, 43(4), pp.833-843.
Kheradvar, A., Groves, E.M., Simmons, C.A., Griffith, B., Alavi, S.H., Tranquillo, R., Dasi,
L.P., Falahatpisheh, A., Grande-Allen, K.J., Goergen, C.J. and Mofrad, M.R., 2015.
Emerging trends in heart valve engineering: Part III. Novel technologies for mitral valve
repair and replacement. Annals of biomedical engineering, 43(4), pp.858-870.

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Running head: ARTIFICIAL HEART VALVE, AN ETHICAL CASE STUDY
Ramos, H.C. and McCauley, J., 2017. Ethical Issues in Organ
Transplantation. Contemporary Kidney Transplantation, pp.1-11
Sievers, H.H., 2017. Heart valve prosthesis. U.S. Patent 9,775,708.
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heart-valve-implicated-in-about-300-deaths.html. [ebook] New York: The New York Times.
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Stakeholders’ Perspectives About and Priorities for Economic Evaluation of Health and
Safety Programs in Healthcare. Workplace health & safety, 64(4), pp.163-174.
Vyavahare, N. and Tam, H., 2018. Bioprosthetic Heart Valves: From a Biomaterials
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Westermarck, E., 2017. Ethical relativity. Routledge